Novartis' Zortress cleared by FDA for liver transplants

Adds to kidney transplant indication in the US

Novartis' Zortress has been given a green light by the FDA to help prevent organ rejection in adult liver transplant recipients, ending a 10-year drought in new immunosuppressants for this indication.

Zortress (everolimus) is already approved in the US for preventing organ rejection in kidney transplant patients, and was cleared for the liver transplant indication last year in Europe, where it is sold as Certican and also used in renal and heart transplants.

Novartis said it was the first drug in the mTOR inhibitor class to be approved in liver transplant in the US and "marks an important milestone for patients and their transplant physicians" as it could reduce exposure to transplant drugs known as calcineurin inhibitors, which can cause side effects.

Tacrolimus and other calcineurin inhibitors are part of the standard-of-care treatment regimen for immunosuppression in liver transplantation, but are linked to adverse effects such as impaired renal function.

Zortress has been approved based on 12-month data from a phase III trial involving 719 liver transplant patients who had received treatment with the calcineurin inhibitor tacrolimus and corticosteroids, with or without mycophenolate mofetil, for the first 30 days following transplant.

After the 30-day period, they were randomised to receive Zortress plus reduced-exposure tacrolimus, Zortress followed by tacrolimus withdrawal at four months, or standard-exposure tacrolimus only.

The new approval will also benefit Thermo Fisher Scientific, which developed and sells a companion diagnostic used to monitor everolimus levels in transplant patients.

Novartis also sells everolimus under the Afinitor brand name as a treatment for kidney, pancreatic and breast cancers, with oncology sales approaching $800m last year, up 85 per cent on 2011. Zortress/Certican achieved sales of $210m in transplantation, a rise of 20 per cent.